STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
This recall has been terminated (originally issued October 4, 2019).
- Company
- Ethicon, Inc. Us
- Recall Initiated
- August 13, 2019
- Posted
- October 4, 2019
- Terminated
- February 11, 2021
- Recall Number
- Z-0047-2020
- Quantity
- 416 each
- Firm Location
- Somerville, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The product does not meet certain internal strength testing specifications.
Distribution
States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States
Lot / Code Info
Lot # LPH946 GTIN: 10705031235823
Root Cause
Under Investigation by firm
Action Taken
Ethicon sent a letter on 8/30/2019. 1. Examine your inventory quarantine the recalled product 2. Do not open the foil pouches to conform contents 3. Complete the Business Reply Form (BRF)confirming receipt of this notice and fax or email it to Stericycle at 888-877-7241 or Ethicon5647@stericycle.com within three (3) business days. 4. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle 5. Distributors are required to return unused impacted STRATAFIX" Spiral PDS" Plus Knotless Tissue Control Devices subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by November 30, 2019. Any non-affected product or impacted product returned after the date specified will not be replaced. If you require any assistance with returning product, please contact Stericycle at 888-759-6910 and reference Event# 5647. If you have additional questions regarding this recall or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.